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…FDA held an online interactive user session, led by Associate Director for Digital Health at CDRH, Bakul Patel, to share a program update and answer attendee questions. The session walked…
…the end of April 2018. This blitz focuses on the sale of e-cigarettes (specifically products under the JUUL brand) to minors at both brick-and-mortar and online retailers. The Agency’s efforts…
…alleged that “online summaries of two studies” contributed to a message of disease treatment or prevention. FDA addressed the use of the studies as follows: [U]nder 21 CFR 101.93(g)(2)(iv)(C), a…
…Drugs and Biologics” (Docket No. FDA-2013-D-0575). A press release is available online (here), and a video recording of the hearing will also be available online (here). Chart for Proposal #3: …
…obtain the drug from an online pharmacy, which dispenses the product on behalf of the manufacturer at a fixed price established by the latter. The manufacturer supplies the product to…
…such as roadside stands, farmers’ markets, Community Supported Agriculture (CSA) programs, and other direct-to-consumer sales platforms, including door-to-door sales; mail, catalog and Internet order, including online farmers markets and online…
…conference online here. DIA is offering FDA Law Blog readers the option for a single day registration rate. To take advantage of the single day registration rate, please call DIA’s…
…shampoos, and sunscreens online with 100% or all natural claims came somewhat as a surprise. According to the consent decrees and the administrative complaint, the FTC charged that the companies…
…website an online forum that gives users the opportunity to post comments about the use of its product . . . the firm is responsible for submitting to FDA the…
…adverse event data for products it marketed. While BioTe Medical (who was inspected by FDA) evidently had an online portal to collect adverse drug event information, and collected over 4000…
…through in-person transactions, by mail, or online, that is different from, in addition to, or otherwise not identical to, the regulations promulgated under this subsection, including any State or local…
…§ 45a does not extend to online and mail order claims as that provision refers to product labels, not to other labeling or advertising. Comments may be submitted until 60…
…Orange Book – that is, all of the prior editions and supplements from the 1979 draft edition to the current 2020 BPCIA Transition edition and beyond – were available online…
…CLE credits for New York, California, Illinois, and Minnesota. Register now to attend in-person or online. The event is presented at the Ropes & Gray, LLP, offices in Boston in…
…since 2013 by DRDMG or its predecessor, the Division of Gastroenterology and Inborn Errors Products (DGIEP), only 1 out of 18 went to an advisory committee meeting. The online records…